MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE ESSENCE; NEBULIZING SYSTEM, NON-HEATED

Model Number	1095060
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging that the nebulizer stopped running during therapy.It was also mentioned that the device was about 3 years old.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
Udi related data quality updates only.The manufacturer previously reported an allegation philips device that the nebulizer stopped running during therapy.It was also mentioned that the device was about 3 years old.There was no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.In this report the manufacturer updated/corrected section d1(brand name), d2b (product code), d3 (manufacturer name, city, and state, company name), d4 (model number, lot number, catalog number, expiration date, serial number, unique device identifier), g4- pma/510(k) number, g4 (combination product), h4 (device manufacture date) and h5 (labeled for single use?).
Additional Manufacturer Narrative
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging that the nebulizer stopped running during therapy.It was also mentioned that the device was about 3 years old.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.**udi related data quality updates only** the udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.

• Brand Name: INNOSPIRE ESSENCE
• Common Device Name: NEBULIZING SYSTEM, NON-HEATED
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18146186
• Report Number: 2518422-2023-30411
• Device Sequence Number: 15200604
• Product Code: BTI
• UDI-Device Identifier: 00383730001807
• UDI-Public: (01)00383730001807
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1095060
• Device Catalogue Number: 1095060
• Device Lot Number: 190221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 10/16/2023; 10/16/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 07/12/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown